Urinary incontinence treatment apparatus

ABSTRACT

A urinary incontinence treatment apparatus comprises an adjustable non-inflatable restriction device ( 434 ) implanted in a patient suffering from urinary incontinence. The restriction device engages the urethra ( 435 ) or urine bladder to restrict the urine passageway. An adjustment device mechanically adjusts the restriction device to restrict the urine passageway or temporarily release the urine passageway to allow the patient to urinate.

[0001] The present invention relates to a urinary incontinence treatmentapparatus for treatment of a patient, who suffers from urinaryincontinence, comprising an adjustable restriction device implantable inthe patient for engaging a portion of the urethra or urine bladder ofthe patient to restrict a urine passageway therein, and an operableadjustment device adapted to mechanically adjust the restriction deviceto change the restriction of the urine passageway.

[0002] Urine incontinence is a widespread problem. Many people arehelped through training of the muscles in the pelvic floor but too manyhave severe problems with urine leakage. Many different solutions tothis problem have been tried. For example, there is a prior manuallyoperated urine incontinence treatment apparatus having an artificialhydraulic sphincter device engaging the urethra and connected to anelastic reservoir implanted in the scrotum or in the region of the labiamajor. A disadvantage of this prior apparatus is that over time hardfibrosis is developed around the reservoir that may cause malfunction ofpumping components. Furthermore, it is a rather complicated task tomanually squeeze the elastic implanted reservoir to pump hydraulic fluidto open the sphincter device when the patient needs to urinate. Inparticular women can get their fingers wet. The created fibrosis willsooner or later become a hard fibrotic layer that may make it even moredifficult to pump the reservoir. Yet a further disadvantage is that theuse of hydraulic fluid always entails a risk of fluid leaking fromimplanted hydraulic components.

[0003] A prior, hydraulic apparatus designed to compress the urethra isdisclosed in U.S. Pat. No. 5,520,606. Prosthetic sphincters with aninflatable cuff that surrounds the urethra or encloses it on two sidesare disclosed in for example U.S. Pat. Nos. 4,571,749 and 4,222,377.U.S. Pat. No. 4,969,474 discloses a hydraulic method for treating bothmen and women with urinary incontinence problems in the same way. Theapparatus of U.S. Pat. No. 4,969,474 includes a reservoir containingfluid and an inflatable compression means designed to compress urethrawithout risking tissue loss or necrosis to occur. An artificialhydraulically operated urethra sphincter employing an external magnet toachieve closure of the urethra cuff is disclosed in U.S. Pat. No.5,562,598.

[0004] A prior mechanical prosthetic sphincter disclosed in U.S. Pat.No. 4,619,245 comprises a manually controllable actuating component forimplanting at a convenient location in the patient's body.

[0005] A prime object of the present invention is to provide a urinaryincontinence treatment apparatus in which the risk of liquid leakagewithin the patient's body is substantially reduced or completelyeliminated.

[0006] A further object of the invention is to provide a urinaryincontinence treatment apparatus, which does not require manualmanipulation of a combined reservoir/pump mechanism in the scrotum orlabia major region of the patient.

[0007] These objects are obtained by an apparatus of the kind statedinitially characterised in that the adjustment device is inoperable bypermanent static magnetic energy. Any other kind of energy, such aselectric, electromagnetic energy or a moving permanent magnetic energy,may be conceivable for operating the adjustment device. As a result, theimplanted restriction device would not be accidentally adjusted if thepatient came close to any permanent magnet.

[0008] Conveniently, the adjustment device may adjust the restrictiondevice in a non-manual or non-invasive manner. The expression“non-manual manner” should be understood to mean that the restrictiondevice is not adjusted by manually touching subcutaneously implantedcomponents of the apparatus. Furthermore, the adjustment device mayadjust the restriction device in a non-thermal manner or in anon-magnetic manner, i.e. magnetic forces may not be involved at allwhen adjusting the restriction device.

[0009] The restriction device preferably is adapted to control, suitablysteplessly, the cross-sectional area of the urine passageway, i.e. toopen and close the urine passageway.

[0010] Generally, the adjustment device is powered for adjusting therestriction device.

[0011] As opposed to prior art urinary incontinence treatment devices,the adjustment device of the invention is not operated by manual forces,such as by manually compressing a fluid containing balloon implanted inthe scrotum. Instead the apparatus of the invention may further comprisea powered operation device for operating the adjustment device. It wouldeven be possible for patients with paresis of the bladder to have afeed-back signal from the system informing the patient when the bladderis full, for example by using some kind of pressure, tension or levelsensor.

[0012] In the various embodiments hereinafter described the restrictiondevice generally is adapted to form an at least substantially closedloop around said portion of the urethra or urine bladder. However, therestriction device may take a variety of different shapes, such as theshape of a square, rectangle or ellipse. The substantially closed loopcould for example be totally flat, i.e. thin as seen in the radialdirection. The shape of the restriction device may also be changedduring use, by rotation or movements of the restriction device in anydirection.

[0013] A physical lumen, such as the urethra or urine bladder, is ofteneasier to restrict by contracting at least two opposite or differentsidewalls of the lumen against each other. Either mechanical orhydraulic solutions may be employed to operate the restriction device.Alternatively, the restriction device may comprise an adjustable cuff, aclamp or a roller for bending the urethra or urine bladder to restrictthe urine passageway therein. Such a cuff, clamp or roller may, also beutilised for squeezing the urethra or urine bladder against humanmaterial inside the body of the patient for an example the sacral boneof the patient.

[0014] Preferably, the restriction device comprises an elongatedrestriction member and forming means for forming the restriction memberinto at least a substantially closed loop around said portion of theurethra or urine bladder, wherein the loop defines a restrictionopening, whereby the adjustment device adjusts the restriction member inthe loop to change the size of the restriction opening.

[0015] The restriction device may be designed for implantation in theabdomen or pelvic region or retroperitoneum of the patient andpreferably may engage the urethra or urine bladder.

[0016] The adjustment device may be incorporated in the restrictiondevice as well as controlled by hydraulic means.

[0017] In accordance with a preferred first adjustment principle, theadjustment device mechanically adjusts the longitudinal extension of theelongated restriction member in a loop form.

[0018] In a preferred embodiment of the invention utilising the firstadjustment principle, the restriction member comprises a main portionand two elongated end portions, and the adjustment device establisheslongitudinal relative displacement between the end portions of therestriction member, so that the size of the restriction opening isadjusted. The forming means may comprise any suitable known orconventional device capable of practising the desired function, such asa spring material forming the elongated restriction member into theloop, so that the restriction opening has a predetermined size, and theadjustment device may adjust the restriction member against the springaction of the spring material. In other words, the restriction membermay comprise a spring clip. The spring material may be integrated in therestriction member.

[0019] Preferably, the adjustment device comprises a movementtransferring member, suitably a drive wheel, in engagement with at leastone of the end portions of the restriction member and operable todisplace the one end portion relative to the other end portion of therestriction member. The drive wheel may advantageously be in engagementwith both of the end portions of the restriction member and be operableto displace the end portions relative to each other. An elongatedflexible drive shaft may be operatively connected to the drive wheel,for transferring manual or motor generated power from a location remotefrom the restriction member. In its simplest embodiment, the drive wheelmay comprise a pulley in frictional engagement with the restrictionmember. As an alternative, a gear rack may be formed on at least one ofthe end portions of the restriction member and the drive wheel maycomprise a gear wheel in mesh with the gear rack. Other suitable knownor conventional mechanisms may also or alternatively be used as theadjustment device.

[0020] The movement transferring member may alternatively comprise atleast one cylinder and a piston, which is movable therein and isconnected to one of the end portions of the restriction member, thepiston being operable to longitudinally displace the one end portion ofthe restriction member relative to the other end portion of therestriction member. Alternatively, the movement transferring means maycomprise two interconnected cylinders and two pistons in the respectivecylinders connected to the end portions, respectively, of therestriction member, the pistons being operable to longitudinallydisplace the end portions of the restriction member relative to eachother. Other known or conventional devices also or alternatively can beused as the movement transferring member.

[0021] A motor, which is fixed relative to the main portion of therestriction member and has a rotating drive shaft operatively connectedto the movement transferring member, may be positioned relative to theelongated restriction member such that the drive shaft extendstransverse thereto. Alternatively, the motor may be positioned relativeto the elongated restriction member such that the drive shaft extendssubstantially tangentially to the loop of the restriction member.

[0022] In another embodiment of the invention utilising the firstadjustment principle, the elongated restriction member is longitudinallyresilient and the adjustment device comprises a contraction device forlongitudinally contracting the resilient restriction member. Preferably,the elongated restriction member comprises a substantially non-resilientmain portion and an end portion forming an elongated helical spring,which is contractible by the contraction device. The contraction devicemay suitably comprise an elongated flexible pulling member connected tothe main portion of the restriction member and extending through thehelical spring to contract the helical spring against an arrestingmember, which is fixed relative to the main portion of the restrictionmember. The pulling member may extend in an elongated tube joined at oneend thereof to the arresting member, so that a motor remote from therestriction member may be attached to the other end of the elongatedtube and pulls the pulling member through the tube to contract thehelical spring.

[0023] In yet another embodiment of the invention utilising the firstadjustment principle, the elongated restriction member comprises anelongated helical spring having a free end, and a body to which thespring is non-rotatably secured at its opposite end. The adjustmentdevice rotates the helical spring in one direction to enlarge the coilsof the helical spring to longitudinally contract the spring and torotate the spring in the opposite direction to reduce the size of thecoils of the spring to longitudinally extend the spring. As a preferredalternative, the restriction member comprises a further elongatedhelical spring having a free end and non-rotatably 20 secured to thebody at its opposite end, and the adjustment device comprises a driveshaft having two opposite end portions connected to the springs,respectively, at their free ends, the helical coils forming left andright hand helices, respectively. The adjustment device mayalternatively comprise a gearing having an input shaft and two oppositealigned output shafts connected to the helical springs, respectively, attheir free ends, the input shaft being connected to the output shafts sothat the output shafts rotate in the opposite directions upon rotationof the input shaft, the helical coils forming the same helices.

[0024] In accordance with a second adjustment principle, the adjustmentdevice mechanically adjusts the restriction member so that at least aportion of a radially innermost circumferential confinement surfaceformed by the restriction member is substantially radially displaced.

[0025] In one embodiment of the invention utilising the secondadjustment principle, the restriction member comprises an elongatedvoltage responsive element forming part of the confinement surface andcapable of bending into a bow in response to a voltage applied acrossthe element, the radius of curvature of the bow being adjustable bychanging the level of the voltage.

[0026] In another embodiment of the invention utilising the secondadjustment principle, the adjustment device changes the diameter of anelastic annular element of the restriction member, which forms theconfinement surface. Preferably, the forming means comprises asubstantially rigid outer annular element coaxially surrounding theelastic annular element, and the adjustment device comprises means forpulling the elastic annular element radially outwardly towards the outerannular element to expand the elastic annular element. For example, thepulling means may comprise a plurality of threads secured to the elasticannular element along the circumference thereof and running from theelastic annular element via guide members attached to the outer annularelement.

[0027] In yet another embodiment of the invention utilising the secondadjustment principle, the forming means comprises a substantially rigidouter annular element, and the restriction member comprises an elongatedhelical spring extending internally along the outer annular element andcontacting the latter. The helical spring forms part of thecircumferential confinement surface and has a free end. The restrictionmember further comprises a body to which the spring is non-rotatablysecured at its opposite end. The adjustment device rotates the helicalspring in one direction to enlarge the coils of the spring to contractthe circumferential confinement surface and rotates the spring in theopposite direction to reduce the size of the coils of the spring toexpand the circumferential confinement surface. As an alternative, whichis preferred, the restriction member comprises two elongated helicalsprings forming part of the circumferential confinement surface andconnected to the body of the restriction member. The adjustment devicerotates each spring in one direction to enlarge the coils of the springto contract the circumferential confinement surface and rotates thespring in the opposite direction to reduce the size of the coils of thespring to expand the circumferential confinement surface.

[0028] In accordance with a third adjustment principle, the restrictionmember comprises at least two separate elements, at least one of whichis pivoted so that it may turn in a plane in which the restrictionmember extends, and the adjustment device turns the pivoted element tochange the size of the restriction opening. Preferably, the restrictionmember comprises a plurality of separate pivoted elements disposed inseries, each pivoted element being turnable in the plane, and theadjustment device turns all of the pivoted elements to change the sizeof the restriction opening. For example, the pivoted elements maycomprise lamellae arranged like the conventional adjustable aperturemechanism of a camera.

[0029] In accordance with a fourth adjustment principle, the adjustmentdevice folds at least two foldable frame elements of the restrictionmember towards each other. Preferably, the foldable frame elementscomprise two substantially or partly semi-circular frame elements whichare hinged together so that the semi-circular elements are swingablerelative to each other from a fully open state in which they form partof a circle to a fully folded state in which they form part of asemi-circle. The same principle may be used with the swingable partsmounted together in one end and not in the other end. Alternatively, therestriction device may comprises two preferably rigid articulatedclamping elements positioned on opposite or different sides of theurethra or urine bladder, and the adjustment device turns the clampingelements toward each other to clamp the urethra or urine bladder betweenthe clamping elements, thereby restricting the urine passageway in theurethra or urine bladder.

[0030] In accordance with a fifth adjustment principle, the adjustmentdevice turns the restriction member around a longitudinal extensionthereof, the elongated restriction member being elastic and varying inthickness as seen in a cross-section thereof. Suitably, the elongatedrestriction member comprises an elastic belt.

[0031] In accordance with a sixth adjustment principle, the adjustmentdevice changes the size of the restriction opening such that the outercircumferential confinement surface of the restriction member ischanged.

[0032] In accordance with a seventh adjustment principle, the adjustmentdevice changes the size of the restriction opening such that the outercircumferential confinement surface of the restriction member isunchanged.

[0033] In accordance with an eighth adjustment principle, the elongatedrestriction member may be flexible, and the adjustment device pulls afirst portion of the flexible restriction member from a second portionof the flexible restriction member opposite the first portion in theloop to squeeze the urethra or urine bladder between the oppositelengths of the elongated flexible restriction member to restrict theurine passageway in the urethra or urine bladder

[0034] In accordance with a ninth adjustment principle, the restrictiondevice comprises at least two elements on opposite or different sides ofurethra or urine bladder, and the adjustment device decreases thedistance between the elements to squeeze the urethra or urine bladderbetween the elements, thereby restricting the urine passageway in theurethra or urine bladder. It is also possible to use only one elementand squeeze the urethra or urine bladder against human bone or tissue.The elements above may as well as all the restriction members mentionedin this application be everything from rigid to soft.

[0035] In accordance with a tenth adjustment principle, the restrictiondevice bends or rotates a portion of the urethra or urine bladder torestrict the urine passageway in the same. For example, the restrictiondevice may comprise at least two bending members, such as cylindrical orhour-glass shaped rollers, positioned on opposite or different sides ofthe urethra or urine bladder and displaced relative to each other alongthe urethra or urine bladder, and the adjustment device may move thebending members against the urethra or urine bladder to bend the latterto restrict the urine passageway in the urethra or urine bladder. Therestriction device may also rotate a portion of the urethra or urinebladder. The bending or rotating members may take any shape or form andbe either hydraulic or non-inflatable.

[0036] Alternatively, the two bending members one placed more distalthan the other may be rotated in opposite directions relative to eachother. With interconnecting material for example flexible bands betweenthe bending members a restriction will occur between the bending memberswhen they are rotated.

[0037] The restriction device may in all applicable embodiments take anyshape or form and be either hydraulic or non-inflatable.

[0038] In all of the above-described embodiments of the invention theadjustment device is conveniently operated by any suitable motor,preferably an electric motor, which may be fixed directly to or beplaced in association with the restriction device, or alternatively belocated remote from the restriction device, advantageously in theabdomen or pelvic region or subcutaneously or in the retroperitoneum ofthe patient. In the latter alternative the motor is advantageouslyconnected to the adjustment device by a flexible power transmissionconduit to permit a suitable positioning of the motor in the abdomen ofthe patient. The motor may be manually activatable, for example by animplanted switch.

[0039] In some of the above described embodiments of the invention,however, the adjustment device may conveniently be operable by ahydraulic operation device, which preferably is manually activatable.The hydraulic operation device may advantageously include hydraulicservo means to facilitate manual activation. As an alternative, thehydraulic device may be powered by an electric motor, which may bemanually activatable or controlled by remote control means. Thecomponents of such a hydraulic operation device may be placed inassociation with the restriction device and/or be located at a suitableplace in the abdomen or be subcutaneously implanted.

[0040] More specifically, a reservoir may be provided containing apredetermined amount of fluid for supplying the hydraulic operationdevice with fluid. The reservoir defines a chamber for the predeterminedamount of fluid and the hydraulic operation device changes the size ofthe chamber. The hydraulic operation device may comprise first andsecond wall portions of the reservoir, which are displaceable relativeto each other to change the size of the chamber of the reservoir. Thefirst and second wall portions of the reservoir may be designed to bedisplaceable relative to each other by manual manipulation thereof,preferably to permit manual pushing, pulling or rotation of any of thewall portions in one direction. Alternatively, the wall portions may bedisplaceable relative to each other by magnetic means (such as apermanent magnet and magnetic material reed switch, or other known orconventional magnetic devices), hydraulic means or electrical controlmeans such as an electric motor. The magnetic means, hydraulic means, orelectrical control means may all be activated by manual manipulation,preferably using a subcutaneously located manually manipulatable device.This control may be indirect, for example via a switch.

[0041] The hydraulic operation device may operate the adjustment devicewith fluid from the reservoir in response to a predetermined firstdisplacement of the first wall portion of the reservoir relative to thesecond wall portion of the reservoir, to adjust the restriction deviceto release the urine passageway, and to operate the adjustment devicewith fluid from the reservoir in response to a predetermined seconddisplacement of the first wall portion of the reservoir relative to thesecond wall portion of the reservoir, to adjust the restriction deviceto restrict the urine passageway. In this embodiment, no pump is used,only the volume of the reservoir is varied. This is of great advantagecompared to the solution described below when a pump is used to pumpfluid between the reservoir and the adjustment device because there isno need for a non-return valve and it is still possible to have fluidgoing both to and from the reservoir.

[0042] As an alternative, the hydraulic operation device may comprise apump for pumping fluid between the reservoir and the adjustment device.The pump may pump fluid both to and away from the adjustment device orhydraulic means controlling the adjustment device. A mechanical manualsolution is proposed in which it is possible to pump in both directionsjust by pushing an activating member in one direction. Anotheralternative is a pump pumping in only one direction and an adjustablevalve to change the direction of fluid to either increase or decreasethe amount of fluid in the reservoir. This valve may be manipulatedmanually, mechanically, electrically, magnetically, or hydraulically.Any kind of motor could of course be used for all the differentoperations as well as wireless remote solutions. The pump may comprise afirst activation member for activating the pump to pump fluid from thereservoir to the adjustment device and a second activation member foractivating the pump to pump fluid from the adjustment device to thereservoir. The activation members may be operable by manualmanipulation, preferably to permit manual pushing, pulling or rotatingthereof in one direction. Suitably, at least one of the activationmembers is adapted to operate when subjected to an external pressureexceeding a predetermined magnitude.

[0043] Alternatively, at least one of the first and second activatingmembers may be operable by magnetic means, hydraulic means or electricalcontrol means such as an electric motor. The magnetic means, hydraulicmeans, or electrical control means may all be activated by manualmanipulating means preferably located subcutaneously. This activationmay be indirect, for example via a switch.

[0044] Advantageously, especially when manual manipulation means areused, a servo means could be used. With servo means less force is neededfor operating the adjustment device. The term “servo means” encompassesthe normal definition of a servo mechanism, i.e. an automatic devicethat controls large amounts of power by means of very small amounts ofpower, but may alternatively or additionally encompass the definition ofa mechanism that transfers a weak force acting on a moving elementhaving a long stroke into a strong force acting on another movingelement having a short stroke. The servo means may comprise a motor,preferably an electric motor, which may be reversible.

[0045] Alternatively, a reverse servo may be employed. The term “reverseservo” is to be understood as a mechanism that transfers a strong forceacting on a moving element having a short stroke into a weak forceacting on another moving element having a long stroke; i.e. the oppositefunction of the above-defined alternative mechanism of a normal servomechanism. A first closed hydraulic system that controls another closedhydraulic system in which hydraulic means of the adjustment device isincorporated may be used. Minor changes in the amount of fluid in asmaller reservoir of the first system could then be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir in the second system. In consequence, the change of volume inthe larger reservoir of the second system affects the hydraulic means ofthe adjustment device. For example, a short stroke that decreases thevolume of the smaller reservoir will cause the larger reservoir tosupply the adjustment device with a large amount of hydraulic fluid,which in turn results in a long mechanical adjustment stroke on therestriction device. The great advantage of using such a reverse servo isthat the larger volume system could be placed inside the abdomen orretroperitoneum where there is more space and still it would be possibleto use manual manipulation means of the smaller system subcutaneously.The smaller reservoir could be controlled directly or indirectly by afluid supply means. The fluid supply means may include another smallreservoir, which may be placed subcutaneously and may be activated bymanual manipulation means. Both the servo and reverse servo may be usedin connection with all of the various components and solutions describedin the present specification.

[0046] Preferably, the reverse servo comprises hydraulic means and amain fluid supply reservoir and eventually an additional fluid supplyreservoir. Both reservoirs define a chamber containing hydraulic fluid,and the hydraulic means comprises first and second wall portions of themain fluid supply reservoir, which are displaceable relative to eachother to change the volume of the chamber of the main fluid supplyreservoir. The hydraulic means may control the adjustment deviceindirectly, e.g. via an increased amount of fluid in the main fluidsupply reservoir, in response to a predetermined first displacement ofthe first wall portion of any of the reservoirs relative to the secondwall portion of the reservoir to close the urine passageway, and tocontrol the adjustment device in response to a second displacement ofthe first wall portion of any reservoir relative to the second wallportion, to indirectly adjust the restriction device to open the urinepassageway. The wall portions of the reservoirs may be designed to bedisplaceable relative to each other by manual manipulation thereof or bedisplaceable relative to each other by manually pushing, pulling orrotating any of the wall portions of the reservoir in one direction.Alternatively, the wall portions of the main fluid supply reservoir maybe displaceable relative to each other by magnetic means, hydraulicmeans or electric control means including an electric motor.

[0047] The magnetic means, hydraulic means, or electrical control meansmay all be activated by manually manipulated means preferably locatedsubcutaneously. This control may be indirect for example via a switch.

[0048] Even in the broadest embodiment of the invention the adjustmentdevice may comprise a servo means. The servo means may comprise ahydraulic operation means, an electrical control means, a magneticmeans, mechanical means or a manual manipulation means. The hydraulicoperation means, electrical control, means, mechanical means or magneticmeans may be activated by manual manipulating means. Using a servosystem will save the use of force when adjusting the adjustment devicewhich may be of importance in many applications, for example when abattery cannot put out enough current although the total energy in thebattery is more than enough to power the system.

[0049] In accordance with a preferred embodiment of the invention, theapparatus comprises implantable electrical components including at leastone, or only one single voltage level guard and a capacitor oraccumulator, wherein the charge and discharge of the capacitor oraccumulator is controlled by use of the voltage level guard. As aresult, there is no need for any implanted current detector and/orcharge level detector for the control of the capacitor, which makes theapparatus simple and reliable.

[0050] All solutions may be controlled by a wireless remote control forcontrolling the adjustment device. The remote control may advantageouslybe capable of obtaining information related to the urine passageway orthe pressure against the restriction device, urethra, or urine bladder,or other important physical parameters and of commanding the adjustmentdevice to adjust the restriction device in response to obtainedinformation. With the wireless remote control the apparatus of theinvention is conveniently controlled by the patient when he so desires,which is of great advantage compared to the prior art procedures. Withthe remote control the apparatus of the invention is convenientlycontrolled to adjust the implanted restriction device to release theurine passageway when to urinate. The restriction device may be operableto open and close the urine passageway. The restriction device maysteplessly control the cross-sectional area of the passageway.

[0051] The apparatus may further comprise a pressure sensor for directlyor indirectly sensing the pressure against the restriction device andthe restriction device may control the cross-sectional area of the urinepassageway in response to signals from the pressure sensor. The pressuresensor may be any suitable known or conventional pressure sensor such asshown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267, 4,571,749,4,407,296 or 3,939,823; or an NPC-102 Medical Angioplasty Sensor. Theadjustment device preferably non-invasively adjusts the restrictiondevice to change the restriction of the urine passageway.

[0052] The adjustment device and/or other energy consuming components ofthe apparatus may be energised with wirelessly transmitted energy fromoutside the patient's body or be powered by an implanted battery oraccumulator.

[0053] The apparatus may further comprise an implanted energytransforming device for transforming wireless energy directly orindirectly into kinetic energy for operation of the restriction device.The energy transforming device may, preferably directly, transform thewireless energy in the form of sound waves into electric energy foroperation of the restriction device. Suitably the energy transformingdevice comprises a capacitor adapted to produce electric pulses from thetransformed electric energy.

[0054] The apparatus of the invention may further comprise an energytransfer means for wireless transfer of energy from outside thepatient's body to the adjustment device and/or other energy consumingimplantable components of the apparatus. The energy transfer means maybe adapted to intermittently transfer the energy, preferably electricenergy, in the form of a train of energy pulses for direct use inconnection with the energising of the energy consuming components of theapparatus. An implanted capacitor having a capacity less than 0,1 μF.may be used for producing the train of energy pulses.

[0055] A motor may be implanted for operating the adjustment device,wherein the energy transfer means is adapted to directly power the motorwith transferred energy. Alternatively, or in combination with themotor, a pump may be implanted for operating the adjustment device,wherein the energy transfer means is adapted to transfer wireless energyin the form of electromagnetic waves for direct power of the pump.Preferably, the pump is not a plunger type of pump, but may comprise aperistaltic or membrane pump.

[0056] The energy transfer means preferably transfers wireless energy inthe form of electromagnetic waves. However, for safety radio waves maybe excluded.

[0057] Alternatively, the energy transferred by the energy transfermeans may comprise an electric field or a magnetic field.

[0058] Most preferred, the energy transferred by the energy transfermeans comprises a signal.

[0059] Preferably, the wireless remote control comprises a separatesignal transmitter or receiver and a signal receiver or transmitterimplanted in the patient. For example, the signal transmitter and signalreceiver may transmit and receive a signal in the form of digitalpulses, which may comprise a magnetic or electric field. Alternatively,which is preferred, the signal transmitter and signal receiver maytransmit and receive an electromagnetic wave signal, a sound wave signalor a carrier wave signal for a remote control signal. The receiver maycomprise an implanted control unit for controlling the adjustment devicein response to a control signal from the signal transmitter.

[0060] The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. The apparatus may comprise anexternal energy transmitter for transmitting wireless energy, whereinthe energiser unit is adapted to transform the wireless energy intoelectric energy. An implanted electric motor may operate the adjustmentdevice and the energiser unit may be adapted to power the electric motorwith the electric energy transformed from the wireless energy.

[0061] The energiser unit may comprise a battery and a switch operableby the wireless energy transmitted by the external transmitter, forconnecting the battery to the implanted energy consuming components ofthe apparatus in an “on” mode when the switch is powered by the wirelessenergy and to keep the battery disconnected from the energy consumingcomponents in a “standby” mode when the switch is not powered.

[0062] The control unit may power such an implanted motor with energyprovided by the energiser unit in response to a control signal receivedfrom the signal transmitter. Any known or conventional signaltransmitter or signal receiver that is suitable for use with a human ormammal patient may be provided as the signal transmitter or signalreceiver of the invention.

[0063] Generally, all of the above signals may comprise electromagneticwaves, such as infrared light, visible light, laser light, micro waves,or sound waves, such as ultrasonic waves or infrasonic waves, or anyother type of wave signals. The signals may also comprise electric ormagnetic fields, or pulses. All of the above-mentioned signals maycomprise digital signals. The signals may be carried by a carrier wavesignal, which in an alternative embodiment may be the same signal as thewireless energy signal. Preferably a digital control signal may becarried by an electromagnetic wave signal. The carrier wave or controlsignal may be amplitude or frequency modulated.

[0064] The motor may be any type of motor, such as a pneumatic,hydraulic or electric motor and the energiser unit may power the motorwith pressurised gas or liquid, or electric energy, depending on thetype of motor. Where the motor is an electric motor, it may powerpneumatic or hydraulic equipment.

[0065] The energiser unit may comprise a power supply and the controlunit may power the motor with energy from the power supply. Preferably,the power supply is an electric power supply, such as a battery, and themotor is an electric motor. In this case, the battery also continuouslypowers at least part of the circuitry of the signal receiver in astandby mode between the adjustments, in order to keep the signalreceiver prepared for receiving signals transmitted from the signaltransmitter.

[0066] The energiser unit may transform energy from the control signal,as the control signal is transmitted to the signal receiver, intoelectric energy for powering the implanted electronic components. Forexample, the energiser unit may transform the energy from the controlsignal into a direct or alternating current.

[0067] In case there is an implanted electric motor for operating theadjustment device the energiser unit may also power the motor with thetransformed energy. Advantageously, the control unit directly powers theelectric motor with electric energy, as the energiser unit transformsthe signal energy into the electric energy. This embodiment isparticularly simple and does not require any recurrent invasive measuresfor exchanging empty power supplies, such as batteries, that is requiredin the first embodiment described above. The motor may also be directlypowered with wirelessly transmitted electromagnetic or magnetic energyin the form of signals, as the energy is transmitted. All the variousfunctions of the motor and associated components described in thepresent specification may be used where applicable.

[0068] For adjustment devices of the type that requires more, but stillrelatively low, power for its operation, the energiser unit may comprisea rechargeable electric power supply for storing the electric energyobtained and the control unit may power the electric motor with energyfrom the rechargeable electric power supply in response to a controlsignal received from the signal transmitter. In this case, therechargeable power supply can be charged over a relatively long time(e.g. a few seconds up to a half-hour) without powering the electricmotor.

[0069] The electric power supply suitably comprises an inexpensivesimple capacitor. In this case, the electric motor may be a steppingmotor. In all embodiments the motor may preferably be able to perform areversing function.

[0070] The signal transmitter may transmit an electromagnetic signal andthe energiser unit may draw radiant energy from the electromagnetic wavesignal, as the latter is transmitted to the signal receiver, andtransform the radiant energy into electric energy.

[0071] Alternatively, the energiser unit may comprise a battery oraccumulator, an electrically operable switch adapted to connect thebattery to the signal receiver in an on mode when the switch is poweredand to keep the battery disconnected from the signal receiver in astandby mode when the switch is not powered, and a rechargeable electricpower supply for powering the switch. The control unit may power theelectric motor with energy from the battery in response to a controlsignal received from the signal transmitter, when the switch is in itson mode. Advantageously, the energiser unit may transfer wave energyfrom the control signal, as the latter is transmitted to the signalreceiver, into a current for charging the rechargeable electric powersupply, which suitably is a capacitor. Energy from the power supply isthen used to change the switch from off (standby mode) to on. Thisembodiment is suited for adjustment devices of the type that requirerelatively high power for their operation and has the advantage that theelectronic circuitry of the signal receiver does not have to be poweredby the battery between adjustments. As a result, the lifetime of thebattery can be significantly prolonged. The switch may be switched withmagnetic, manual or electric energy.

[0072] As an example, the signal transmitter may transmit anelectromagnetic wave signal and the energiser unit may draw radiantenergy from the electromagnetic wave signal, as the latter istransmitted to the signal receiver, and may transform the radiant energyinto the current. The energiser unit suitably comprises a coil of thesignal receiver for inducing an alternating current as theelectromagnetic wave signal is transmitted through the coil and arectifier for rectifying the alternating current. The rectified currentis used for charging the rechargeable power source.

[0073] Alternatively, the signal transmitter and receiver may solely beused for a control signal and a further pair of signal transmitter andreceiver may be provided for transferring signal energy to implantedcomponents. By such a double system of signal transmitters and receiversthe advantage is obtained that the two systems can be designed optimallyfor their respective purposes, namely to transmit a control signal andto transfer energy from an energy signal. Accordingly, the apparatus mayfurther comprise an external energy transmitter for transmittingwireless energy, wherein the energiser unit comprises a battery and anoperable switch for connecting the battery to the signal receiver in an“on” mode when the switch is powered and for keeping the batterydisconnected from the signal receiver in a “standby” mode when theswitch is not powered, and the external energy transmitter powers theswitch. Suitably, the energy transmitter may directly power the switchwith the wireless energy to switch into the “on” mode.

[0074] As should be realised by a skilled person, in many of theabove-described embodiments of the invention the adjustment device maybe operated by control means or manual manipulation means implantedunder the skin of the patient, such as a pump, an electrical switch or amechanical movement transferring means. In the manual embodiment it isnot necessary to use a motor for operating the adjustment device.

[0075] In embodiments including hydraulic transmission means, aninjection port connected to the hydraulic means may be provided forenabling, normally single, once-and-for-all, calibration of the amountof fluid in the hydraulic system.

[0076] In all embodiments a motor may be operatively connected to theadjustment device. A reversing device may be implanted in the patientfor reversing the motor.

[0077] The adjustment device may be adapted to hydraulically adjust therestriction device by using hydraulic means which is devoid of hydraulicfluid of the kind having a viscosity that substantially increases whenexposed to heat or a magnetic field, i.e. the hydraulic fluid would notbecome more viscous when exposed to heat or influenced by magneticforces.

[0078] The restriction device is operable to open and close the urinepassageway steplessly and preferably controlled by a remote control.Preferably, a pressure sensor is used for directly or indirectly sensingthe pressure against the restriction device or urethra to prevent anynecrosis of the human tissue to occur. The restriction device maypreferably be controlled in response to signals from the pressuresensor. The motor which preferably is used to adjust the restrictiondevice must then be capable of performing a reversible function that isto say, be capable of reversing the driving direction of the motor.

[0079] Preferably the adjustment device is directly energised withwirelessly transmitted energy from outside the patient's body. Theimplanted energy transforming device transforms wireless energy directlyor indirectly into kinetic energy for operation of the restrictiondevice. In accordance with another embodiment it would also be possibleto use an implanted accumulator or battery and control this implantedenergy source from outside the patient's body to supply engergy to theadjustment device or other energy consuming implanted-parts of theapparatus.

[0080] It is possible to use two or more restricting devices forengaging the urethra or urine bladder.

[0081] All the above-described various components, such as the motor,pump and capacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable.

[0082] All the various ways of transferring energy and controlling theenergy presented in the present specification may be practised by usingall of the various components and solutions described.

[0083] The invention also provides a method for treating urinaryincontinence of a patient comprising surgically implanting in the bodyof a patient suffering from urinary incontinence an adjustable,preferably non-inflatable restriction device which directly engages theurethra or urine bladder to restrict the urine passageway, and whendesired, mechanically adjusting the restriction device to temporarilyopen the urine restriction device.

[0084] The invention further provides a method for treating urinaryincontince, comprising the steps of: placing at least two laparascopicaltrocars in the body of a patient suffering from urinary incontinence,inserting a dissecting tool through the trocars and dissecting in areaof the urethra or urine bladder in the abdominal or pelvic orretroperitoneal surroundings, placing at least one adjustablerestriction device in the dissected area engaging the urethra andadjusting the restriction device to normally restrict the urinepassageway and to release the urine passageway when the patient wants tourinate. A mechanical restriction device may be used when practisingthis method, preferably also in a non-manual manner i.e. withouttouching subcutaneously implanted components of the apparatus. A poweredadjustment device working in a non-magnetic manner may also be used.

[0085] The method may further comprise implanting a source of energy inthe patient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device.

[0086] It should generally be understood that all the above embodimentsmight be combined in any working combinations.

[0087] The invention is described in more detail in the following withreference to the accompanying drawings, in which

[0088]FIG. 1 is a schematic sectional view of a preferred firstembodiment of the urinary incontinence treatment apparatus in accordancewith the invention;

[0089]FIGS. 2 and 3 are cross-sectional views taken along the linesII-II and III-III, respectively, of FIG. 1;

[0090]FIGS. 4 and 5 schematically show two alternative designs of theembodiment of FIG. 1;

[0091]FIG. 6 schematically illustrates a motor arrangement for thedesign according to FIG. 5;

[0092]FIG. 7 is a schematic sectional view of a second embodiment of theapparatus in accordance with the invention;

[0093]FIG. 8 schematically illustrates a hydraulic transmision conduitfor the embodiment of FIG. 7;

[0094]FIG. 9 is a schematic sectional view of a third embodiment of theapparatus in accordance with the invention;

[0095]FIG. 10 is a modification of the embodiment of FIG. 9;

[0096]FIG. 11 is a schematic view of a fourth embodiment of theapparatus in accordance with the invention;

[0097]FIGS. 12 and 13 are enlarged details of the embodiment of FIG. 11;

[0098]FIG. 14 is a cross-section along the line XIV-XIV of FIG. 11;

[0099]FIG. 15 is a schematic view of a fifth embodiment of the apparatusin accordance with the invention;

[0100]FIG. 16 is an enlarged detail of FIG. 15;

[0101]FIG. 17 is a cross-section along the line XVII-XVII of FIG. 15;

[0102] FIGS. 18 to 21 are schematic sectional views of a sixth, seventh,eighth and ninth embodiments, respectively, of the apparatus inaccordance with the invention;

[0103]FIGS. 22 and 23 illustrate a fully open and a reduced restrictionopening, respectively, of the embodiment of FIG. 21;

[0104]FIG. 24 is a schematic view of a tenth embodiment of the apparatusin accordance with the invention;

[0105]FIG. 25 is an enlarged detail of the embodiment of FIG. 24;

[0106]FIGS. 26 and 27 illustrate a fully open and a reduced restrictionopening, respectively, of the embodiment of FIG. 24;

[0107]FIG. 28 schematically illustrates a cushion arrangement forprotecting the tissue of the patient;

[0108] FIGS. 29A-D is a block diagram of four different principalembodiments of the invention;

[0109] FIGS. 30A-D are cross-sectional views of a pump mechanismaccording to FIG. 29C, which pumps fluid in opposite directions bymechanically pushing a wall portion in only one direction;

[0110]FIG. 31 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 29B or30B;

[0111]FIG. 32 is a cross-sectional view of a reservoir having a variablevolume adjustable by manual manipulation, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 29B or29D;

[0112]FIG. 33A is a front view of a hydraulic, pneumatic or mechanicalreverse servo system in accordance with a particular embodiment of theprincipal embodiment shown in FIG. 29D;

[0113]FIG. 33B is a cross-sectional view taken along line VB-VB of FIG.33A;

[0114]FIG. 34 is a block diagram illustrating remote control componentsof the apparatus of the invention;

[0115]FIG. 35 is a schematic view of a circuitry used for the system ofthe block diagram of FIG. 34;

[0116]FIGS. 36A and 36B are schematic views of an eleventh embodiment ofthe apparatus in accordance with the invention;

[0117]FIGS. 37A and 37B are schematic views of a twelfth embodiment ofthe apparatus in accordance with the invention;

[0118]FIG. 38 is a schematic view of a thirteenth embodiment of theapparatus in accordance with the invention;

[0119]FIGS. 39A, 39B and 39C are a schematic front view and schematicsectional views, respectively, of a fourteenth embodiment of theapparatus in accordance with the invention;

[0120]FIGS. 40A through 44B are five modifications of the embodiment ofFIGS. 39A-39C;

[0121]FIG. 45 illustrates the apparatus of the invention with animplanted restriction device engaging the urethra.

[0122] Referring to the drawing FIGURES, like reference numeralsdesignate identical or corresponding elements throughout the severalfigures.

[0123] FIGS. 1-3 show a preferred embodiment of the urinary incontinencetreatment apparatus of the invention comprising a restriction devicehaving an elongated restriction member in the form of a circularresilient core 2 with two overlapping end portions 4,6. The core 2defines a substantially circular restriction opening and is enclosed inan elastic soft hose 8 except at a releasable and lockable joint 10 ofthe core 2, which when released enables application of the core 2 withits hose 8 around a tissue of a patient, such as the urethra or urinebladder. The materials of all of these elements are biocompatible sothat the patient's body will not reject them. A mechanical adjustmentdevice 12 for mechanically adjusting the longitudinal extension of thecore 2 to change the size of the restriction opening comprises a drivewheel 14 in frictional engagement with the overlapping end portions 4,6of the core 2. The drive wheel 14 is journalled on a holder 16 placed inthe hose 8 and provided with two counter pressure rollers 18,20 pressingthe respective end portions 4, 6 of the core 2 against the drive wheel14 to increase the frictional engagement there between. An electricmotor 22 is connected to the drive wheel 14 via a long flexible driveshaft 24 and is moulded together with a remote controlled power supplyunit 26 in a body 28 of silicone rubber. The length of the flexibledrive shaft 34 is selected so that the body 28 can be placed in adesired position in the patient's body, suitably in the abdomen.

[0124] When the patient doesn't want to relieve himself (urinate), hecontrols the power supply unit 26 to power the electric motor 22 to turnthe drive wheel 14 in one direction to reduce the diameter of the core2, so that the tissue is squeezed and the urine passageway isrestricted. When the patient wishes to urinate, he controls the powersupply unit 26 to power the electric motor 22 to turn the drive wheel 14in the opposite direction to increase the diameter of the core 2, sothat the urine passageway is released and opens.

[0125] Alternatively, a rack gear may be formed on one of the endportions 4,6 of the core 2 and the drive wheel 14 may be replaced by adrive gear wheel connected to the other end portion of the core 2 and inmesh with the rack gear.

[0126]FIG. 4 shows an embodiment of the invention which is identical tothe embodiment of FIGS. 1-3, except that the motor 22 is encapsulated ina lateral protrusion 30 of the hose 8 so that it is fixed to the core 2and has a short drive shaft 32 onto which the drive wheel 14 is mounted,and that the motor 22 is positioned relative to the circular core 2 suchthat the drive shaft 32 extends radially thereto.

[0127]FIG. 5 shows an embodiment of the invention which likewise isidentical to the embodiment of FIGS. 1-3, except that the motor 22 isencapsulated in the hose 8 so that it is fixed to the core 2 and has ashort drive shaft 32, and that the motor 22 is positioned relative tothe core 2 such that the drive shaft 32 extends substantiallytangentially to the circular core 2. There is an angular gearing 34connecting the drive shaft 32 to the drive wheel 14.

[0128]FIG. 6 shows a suitable arrangement for the motor 22 in theembodiment of FIG. 5, comprising a first clamping member 36 secured toone end portion of the core 2 and a second clamping member 38 secured tothe other end portion 6 of the core 2. The motor 22 is secured to thefirst clamping member 36 and is operatively connected to a worm 40 via agear transmission 42. The worm 40 is journalled at its opposite ends onholders 44 and 46, which are rigidly secured to the clamping member 36and the motor 22, respectively. The second clamping member 38 has apinion in mesh with the worm 40. When the motor 22 is powered the worm40 rotates and pulls the end portion 6 of the core 2 in one or theopposite longitudinal direction, so that the diameter of thesubstantially circular core 2 is either increased or decreased.

[0129]FIG. 7 shows an embodiment of the invention in which the elongatedrestriction member comprises a core 48 and a helical spring 50. A springcontracting means in the form of a flexible pulling member 52, i.e. astring, wire or cable, is connected to the core 48 at one end thereofand extends through the helical spring 50. A hydraulic motor in the formof a cylinder/piston unit 54 is adapted to pull the flexible pullingmember 52 to contract the helical spring 50 against an arresting member56, which is fixed relative to the core 48. A tube 58 hinged to thearresting member 56 extends between the cylinder/piston unit 54 and thearresting member 56, the flexible pulling member 52 running through thetube 58 and being connected to the piston of the cylinder/piston unit54.

[0130]FIG. 8 shows a similar embodiment in which a hydraulictransmission conduit 59 is provided between two piston-cylinderassemblies 54, for use as the hydraulic motor/device in FIG. 7.

[0131]FIG. 9 shows an embodiment of the invention in which therestriction member comprises two elongated helical springs 60 and 62having free ends, and a body 64 to which the springs 60,62 arenon-rotatably secured at their opposite ends. The body 64 comprises twoseparate, parts secured to opposite end portions of the enclosingelastic hose 8 and is designed with a releasable and lockable jointbetween the separate parts. An adjustment device in the form of a driveshaft 66 has two opposite end portions connected to the helical springs60,62, respectively, at their free ends. The coils of the springs 60,62form left and right hand helices, respectively. A motor 68 is adapted torotate the drive shaft 66 in one direction to enlarge the coils of thehelical springs 60,62 to longitudinally contract the springs 60,62 andto rotate the drive shaft 66 in the opposite direction to reduce thesize of the coils of the springs 60,62 to longitudinally extend thesprings 60,62. Thus, the elongated helical springs 60,62 defines arestriction opening, the size of which is increased when the springs60,62 are extended and decreased when the springs 60,62 are contracted.

[0132]FIG. 10 shows an embodiment according to the invention which isidentical to the embodiment of FIG. 9, except that the adjustment devicecomprises a gearing having an input shaft 72 and two opposite alignedoutput shafts 74 and 76 connected to the helical springs 60 and 62,respectively, at their free ends. The input shaft 72 is connected to theoutput shafts 74,76 such that they rotate at opposite directions uponrotation of the input shaft 72. The coils of the springs 60, 62 form thesame helices.

[0133] FIGS. 11-14 show an embodiment of the device of the invention inwhich a hydraulic motor comprises two interconnected cylinders 78 and 80and two pistons 82 and 84 in the respective cylinders 78,80. Thecylinders 78,80 have a common fluid supply inlet member 86, whichtogether with the cylinders 78,80 takes the shape of an Y-pipe. Therestriction member comprises an elongated resilient arcuate core 88. Theadjustment device comprises two bars 90 and 92 secured to opposite endsof the core 88 and connected to the pistons 82 and 84, respectively. Thecore 88 defines a restriction opening and is provided with a releasableand lockable joint 94 (FIG. 13) to permit application of the core 88around the tissue soft elastic hose 96 except at the joint 94 and theinlet member 86 encloses the core 88 and the cylinders 90,92. The hose96 has an outer tubular wall 98 and a central coaxial inner tubular wall100, which is fixed to the outer wall 98 by spoke members 102 (FIG. 14).The core 88 is loosely fit in the inner tubular wall 100. By supplyingfluid to or withdrawing fluid from the inlet 86 the pistons 82 and 84will, move towards or from each other, so that the restriction openingdefined by the core 88 is changed by the longitudinal displacement ofthe bars 90,92.

[0134] FIGS. 15-17 show an embodiment of the invention which isidentical to the embodiment of FIGS. 11-14, except that the adjustmentdevice comprises an elongated voltage responsive element 104 secured tothe opposite ends of the core 88, so that the core 88 and the element104 form the restriction member. The element 104 is capable of bendinginwardly into a bow in response to a voltage applied across the element104. The radius of curvature of the bow is adjustable by changing thelevel of the voltage applied to element 104.

[0135]FIG. 18 shows an embodiment of the invention comprising a loopforming means in the form of a substantially rigid outer circularelement 106 with a releasable and lockable joint 108. In this embodimentthe restriction member comprises an elastic inner circular element 110formed by the innermost wall portion of an elastic hose 112 extendingalong the outer element 106. The inner circular element 110 is disposedconcentrically within the outer circular element 106. The adjustmentdevice comprises a plurality of threads 114 secured to the elastic innerelement 110 along the circumference thereof and running from the innerelement 110 via guide members 116 attached to the outer element 106. Bypulling all the threads 114 the inner elastic element 110 is pulledunder expansion radially outwardly towards the outer element 106.

[0136]FIG. 19 shows an embodiment which is identical to the embodimentof FIG., 9, except that it comprises a loop forming means in the form ofa substantially rigid outer circular element 118 supporting the helicalsprings 60,62, and a soft elastic inner wall 120 extending along thesprings 60,62. When the motor 68 rotates the helical springs 60, 62 in adirection that enlarges the coils of the springs 60,62, the coils areforced by the rigid outer element 118 to expand radially inwardlythereby reducing the size of the restriction opening formed by thecircumferential confinement surface of the restriction member (springs60,62 and body 64).

[0137]FIG. 20 shows an embodiment of the invention in which arestriction member comprises a plurality of arcuate lamellae 122arranged like the conventional adjustable aperture mechanism of acamera. The adjustment device, not shown, is conventional and isoperated by a motor 124 to adjust the lamellae 122 to change the size ofan restriction opening defined by the lamellae 122.

[0138] FIGS. 21-23 show an embodiment of the invention in which arestriction member comprises two semi-circular elements 126 and 128which are hinged together such that the semi-circular elements 126,128are swingable relative to each other between a fully open state in whichthey substantially form a circle, illustrated in FIG., 22 and an angularstate, in which the size of the restriction opening defined by thesemi-circular elements 126,128 is reduced, illustrated in FIG., 23. Theadjustment device, not shown, is conventional and is operated by a motor130 to swing the semi-circular elements 126,128 relative to each other.

[0139] FIGS. 24-27 show an embodiment of the invention in which arestriction member comprises an elastic belt 130 forming a circle andhaving a substantially oval cross-section. The restriction member 130 isprovided with a releasable and lockable joint 132. An elastic doublewalled hose 134 encloses the belt 130 except at the joint 132. Theadjustment device, not shown, is conventional and is operated by a motor136 to turn the belt 130 around the longitudinal extension thereofbetween a fully open state, in which the inner broader side of the belt130 forms a substantially cylindrical surface, illustrated in FIG. 26,and a reduced open state, in which the inner broader side of the belt130 forms a substantially conical surface, illustrated in FIG. 27.

[0140]FIG. 28 schematically illustrates a cushion arrangement forprotecting the tissue, comprising a plurality of cushions 138 disposedin series along a substantially circular holding member 140. Thiscushion arrangement may be utilised in any of the above-describedembodiments of the invention.

[0141] FIGS. 29A-D provide a block diagram of four different hydraulictransmission configurations. FIG. 29A shows an adjustment device 202, aseparate reservoir 204, a one way pump 206 and an alternate valve 208.FIG. 29B shows the adjustment device 202 and an adjustable reservoir210. FIG. 29C shows the adjustment device 202, a two-way pump 212 andthe reservoir 204. FIG. 29D shows a reverse servo system with a firstclosed system controlling a second system. The servo system comprises anadjustable servo reservoir 210 and a passive adjustable fluid supplyreservoir 214. Any of the reservoirs can be the active reservoir, eitherthe servo reservoir 210 or the fluid supply reservoir 214. The reservoir214 controls a larger adjustable reservoir 216, which is used for theoperation of the adjustment device 202 for changing the restrictionopening of the restriction member.

[0142] FIGS. 30A-D are cross-sectional views of a pump mechanism adaptedto pump fluid in both directions only by mechanically pushing a separatesealing wall portion 218 in one direction. FIG. 30A shows a piston 220pushed forwards against a spring 222 towards the wall portion 218 andlocated in a pump housing 224 conducting fluid from a right upper fluidpassage 226 of the housing 224 to a left fluid passage 228 of thehousing 224. A main valve 230 is open and a nonreturn valve 232 isclosed. FIG. 30B illustrates the first pump movement in which the piston220 has moved forwards and reaches the wall portion 218. FIG. 30Cillustrates how the piston 220 moves backwards by the action of thespring 222. The main valve 230 is now closed and the nonreturn valve 232is open for fluid from the right upper passage 226. FIG. 30D illustrateshow the piston 220 is moved further downwards from its positionaccording to FIG. 30B while pushing the wall portion 218 downwardsagainst a second spring 234 that is stronger than spring 222, so thatfluid escapes from a right lower fluid passage 236. When moving thepiston 220 backwards from the position of FIG. 30D, fluid enters theleft fluid passage 228 and a valve 238 in the lower right fluid passage236 closes.

[0143]FIG. 31 is a cross-sectional view of a reservoir 240 defining achamber 242, the size of which is variable and is controlled by a remotecontrolled motor 244, in accordance with FIG. 29B or 29D. The reservoir240 and the motor 244 are placed in a housing 246. The chamber 242 isvaried by moving a large wall 248. The wall 248 is secured to a nut 250,which is threaded on a rotatable spindle 252. The spindle 252 is rotatedby the motor 244 via an angular gearing, which comprises two conicalgear wheels 254 and 256 in mesh with each other. The motor 244 ispowered by a battery 258 placed in the housing 246. A signal receiver260 for controlling the motor 244 is also placed in the housing 246.Alternatively, the battery 258 and the signal receiver 260 may bemounted in a separate place. The signal receiver may comprise any knownor conventional device which is capable of receiving a control signaland then operating the motor 244.

[0144]FIG. 32 is a cross-sectional view of a reservoir 262 defining achamber 264, the size of which is variable and is controlled by manualmanipulation. A gable wall portion 266 of an open ended innercylindrical housing 68 is adapted to be pushed downwards to fit in adesired locking groove 270 of a plurality of locking grooves 270 on themantle wall of the cylindrical housing 268, to reduce the size of thechamber 64. The inner cylindrical housing 268 is suspended by springs272 and is telescopically applied on an outer cylindrical housing 274.When pushing the inner cylindrical housing 268 it moves downwardsrelative to the outer cylindrical housing 274 causing the gable wallportion 266 to release from the locking groove 270 and move upwardsrelative to the inner cylindrical housing 28. When the inner housing 268is moved upwardly by the action of the springs 272 the size of thechamber 264 is increased.

[0145] FIGS. 33A and 33B: show a servo means comprising a mainring-shaped fluid reservoir 276 defining a chamber 278, the size ofwhich is variable. Centrally positioned in the main ring-shapedreservoir 276 there is a servo fluid reservoir 280 defining a chamber282, the size of which is variable. The chamber 282 of the servoreservoir 280 is significantly smaller than the chamber 278 of the mainreservoir 276. The two reservoirs 276 and 280 are situated between twoopposite separate walls 284 and 286, and are secured thereto. Whenchanging the amount of fluid in the servo reservoir 280, the twoopposite walls 284,286 are moved towards or away from each other,whereby the size of the chamber 278 of the main reservoir 276 ischanged.

[0146]FIG. 34 shows the basic parts of a remote control system of theapparatus of the invention including a motor, for instance the electricmotor 22. In this case, the remote control system is based on thetransmission of an electromagnetic wave signal, often of a highfrequency in the order of 100 kHz-1 gHz, through the skin 330 of thepatient. In FIG. 34, all parts placed to the left of the skin 330 arelocated outside the patient's body and all parts placed to the right ofthe skin 330 are implanted in the patient's body.

[0147] An external signal transmitting antenna 332 is to be positionedclose to a signal receiving antenna 334 implanted in the patient's bodyclose to the skin 330. As an alternative, the receiving antenna 334 maybe placed for example inside the abdomen of the patient. The receivingantenna 334 comprises a coil, approximately 1-100 mm, preferably 25 mmin diameter, wound with a very thin wire and tuned with a capacitor to aspecific high frequency. A small coil is chosen if it is to be implantedunder the skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The transmitting antenna 332comprises a coil having about the same size as the coil of the receivingantenna 334 but wound with a thick wire that can handle the largercurrents that is necessary. The coil of the transmitting antenna 332 istuned to the same specific high frequency as the coil of the receivingantenna 334.

[0148] An external control unit 336 comprises a microprocessor, a highfrequency electromagnetic signal generator and a power amplifier. Themicroprocessor of the control unit 336 is adapted to switch on/off thegenerator and to modulate signals generated by the generator to senddigital information via the power amplifier and the antennas 332,334 toan implanted control unit 338. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A keypad placed on the external control unit 336 is connected tothe microprocessor thereof. The keypad is used to order themicroprocessor to send a digital signal to either increase or decreasethe size of the restriction opening defined by the loop of therestriction member (e.g. as described above). The microprocessor startsa command by applying a high frequency signal on the antenna 332. Aftera short time, when the signal has energised the implanted parts of thecontrol system, commands are sent to increase or decrease the size ofthe restriction opening of the restriction member in predefined steps.The commands are sent as digital packets in the form illustrated below.Start pattern Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

[0149] The commands are sent continuously during a rather long timeperiod (e.g. 30 seconds or more). When a new increase or decrease stepis desired the count byte is increased by one to allow the implantedcontrol unit 338 to decode and understand that another step is demandedby the external control unit 336. If any part of the digital packet iserroneous, its content is simply ignored.

[0150] Through a line 340, an implanted energiser unit 326 draws energyfrom the high frequency electromagnetic wave signal received by thereceiving antenna 334. The energiser unit 326 stores the energy in apower supply, such as a large capacitor, powers the control unit 338 andpowers the electric motor 22 via a line 342.

[0151] The control unit 338 comprises a demodulator and amicroprocessor. The demodulator demodulates digital signals sent fromthe external control unit 336. The microprocessor of the control unit338 receives the digital packet, decodes it and, provided that the powersupply of the energiser unit 326 has sufficient energy stored, sends asignal via a signal line 344 to the motor 22 to either increase ordecrease the size of the restriction opening of the restriction memberdepending on the received command code.

[0152] Alternatively, the energy stored in the power supply of theenergiser unit may only be used for powering a switch, and the energyfor powering the motor 22 may be obtained from another implanted powersource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect the battery to the control unit 338 inan “on” mode when the switch is powered by the power supply and to keepthe battery disconnected from the control unit in a “standby” mode whenthe switch is not powered.

[0153] With reference to FIG. 35, the remote control systemschematically described above will now be described in accordance with amore detailed embodiment. The external control unit 336 comprises amicroprocessor 346, a signal generator 348 and a power amplifier 350connected thereto. The microprocessor 346 is adapted to switch thesignal generator 348 on/off and to modulate signals generated by thesignal generator 348 with digital commands that are sent to implantedcomponents of the device of the invention. The power amplifier 350amplifies the signals and sends them to the external signal transmittingantenna 332. The antenna 332 is connected in parallel with a capacitor352 to form a resonant circuit tuned to the frequency generated by thesignal generator 348.

[0154] The implanted signal receiving antenna coil 334 forms togetherwith a capacitor 354 a resonant circuit that is tuned to the samefrequency as the transmitting antenna 332. The signal receiving antennacoil 334 induces a current from the received high frequencyelectromagnetic waves and a rectifying diode 360 rectifies the inducedcurrent, which charges a storage capacitor 358. A coil 356 connectedbetween the antenna coil 334 and the diode 360 prevents the capacitor358 and the diode 360 from loading the circuit of the signal receivingantenna 334 at higher frequencies. Thus, the coil 356 makes it possibleto charge the capacitor 358 and to transmit digital information usingamplitude modulation.

[0155] A capacitor 362 and a resistor 364 connected in parallel and adiode 366 forms a detector used to detect amplitude modulated digitalinformation. A filter circuit is formed by a resistor 368 connected inseries with a resistor 370 connected in series with a capacitor 372connected in series with the resistor 368 via ground, and a capacitor374, one terminal of which is connected between the resistors 368,370and the other terminal of which is connected between the diode 366 andthe circuit formed by the capacitor 362 and resistor 364. The filtercircuit is used to filter out undesired low and high frequencies. Thedetected and filtered signals are fed to an implanted microprocessor 376that decodes the digital information and controls the motor 22 via anH-bridge 378 comprising transistors 380,382,384 and 386. The motor 22can be driven in two opposite directions by the H-bridge 378.

[0156] The microprocessor 376 also monitors the amount of stored energyin the storage capacitor 358. Before sending signals to activate themotor 22, the microprocessor 376 checks whether the energy stored in thestorage capacitor 358 is enough. If the stored energy is not enough toperform the requested operation, the microprocessor 376 waits for thereceived signals to charge the storage capacitor 358 before activatingthe motor 22.

[0157]FIGS. 36A and 36B show an embodiment of the apparatus of theinvention comprising a restriction device 402 having an elongatedflexible restriction member 404, such as a belt, a cord or the like. Theflexible member 404 extends in a loop around the tissue, suitably theurethra of the patient. (Alternatively, the flexible member 404 maycomprise two separate parts on opposite sides of the urethra. Oneportion 404A of member 404 is attached to a frame 408 and anotherportion 404B of member 404 opposite portion 404A in the loop of theflexible member 404 is connected to an adjustment device 410, which isfixed to the frame 408. The adjustment device 410 pulls the flexiblemember 404 in the direction from portion 404A to squeeze the urethrabetween two opposite lengths of the flexible member 404 to therebyrestrict the urine passageway in the urethra 406, see FIG. 36A, andreleases the urethra from the flexible member 404 to thereby increasethe urine passageway to allow the patient to urinate 406, see FIG. 36B.

[0158]FIGS. 37A and 37B show an embodiment of the apparatus of theinvention comprising a restriction device 412 having two plate or barelements 414 on opposite sides of the urethra 406. An adjustment device416 moves the elements 412 in parallel towards each other to squeeze theurethra 406 between the elements 412 to thereby restrict the urinepassageway in the urethra 406, see FIG. 37A, and moves the elements 412away from each other to release the urethra 406, see FIG. 37B.

[0159]FIG. 38 shows an embodiment of the apparatus of the inventioncomprising a restriction device 418 having two rigid articulatedclamping elements 420 positioned on opposite sides of the urethra 406.An adjustment device 422 turns the clamping elements 420 toward eachother to clamp the urethra 406 between the clamping elements 420 tothereby restrict the urine passageway in the urethra 406, and turns theclamping elements 420 away from each other to release the urethra 406from the clamping elements 420 to thereby decrease the restriction ofthe urine passageway to allow the patient to urinate.

[0160]FIGS. 39A, 39B and 39C show an embodiment of the apparatus of theinvention comprising a restriction device 424 having three bendingmembers in the form of cylindrical rollers 426, 428 and 430 displacedrelative one another in a row along the urethra 406 and positionedalternately don opposite sides of the urethra 406. (Alternatively, eachroller 426, 428 and 430 may take the shape of an hourglass.) Anadjustment device 432 moves the two outer rollers 426,430 laterallyagainst the urethra 406 in one direction and the intermediate roller 428against the urethra 406 in the opposite direction to bend the urethra tothereby restrict the urine passageway in the urethra 406, see FIG. 39B.To increase the urine passageway to allow the patient to urinate 406,the adjustment device 432 moves the rollers 426-430 away from theurethra 406 to release it from the rollers 426-430, see FIG. 39C.

[0161]FIGS. 40A through 44B schematically illustrates modifications ofthe above embodiment according to FIGS. 39A-39C. Thus, FIGS. 40A and 40Bshow an embodiment similar to that of FIGS. 39A-39C except that thebending members are oval and not rotatable.

[0162]FIGS. 41A and 41B show an embodiment similar to that of FIGS. 40Aand 40B except that the oval bending members are rotatable to releasethe urethra, see FIG. 41A, and squeeze the urethra, see FIG. 41B.

[0163]FIGS. 42A and 42B show an embodiment similar to that of FIGS.39A-39C except that the intermediate roller has a changeable diameter torelease the urethra, see FIG. 42A, and squeeze the urethra, see FIG.42B.

[0164]FIGS. 43A and 43B show an embodiment similar to that of FIGS.37A-37C except that the elements are replaced by two cylindrical rollerspositioned on opposite sides of the urethra.

[0165] Finally, FIGS. 44A and 44B show an embodiment substantiallysimilar to that of FIGS. 43A and 43B except that the restriction deviceis curved to form an S-shaped curvature of the urethra.

[0166]FIG. 45 schematically illustrates how any of the above-describedembodiments of the urinary incontinence treatment apparatus of theinvention may be implanted in a patient. Thus, the apparatus comprisesan adjustable restriction device 434 extending around the urethra 435 ofthe patient and a motor operated adjustment device for mechanicallyadjusting the restriction device 434 to squeeze the urethra or urinebladder to thereby restrict the urine passageway. The motor, not shown,is integrated in the adjustment device and is reversible to operate theadjustment device to release the urethra or urine bladder from therestriction device 434 to allow the patient to urinate. A wirelessremote control of the apparatus comprises an external signal transmitter438 incorporated in a portable remote-control unit and an implantedsignal receiver 440, which comprises a control unit for controlling theadjustment device in response to a control signal, for example anelectromagnetic wave signal, from the transmitter 438. The signalreceiver 440 further comprises an energiser unit which transforms energyfrom the control signal transmitted by the transmitter 438 into electricenergy for energy consuming implanted components of the apparatus, suchas the motor for operating the adjustment device. The electric energy isconducted via an implanted conductor 442 from the signal receiver 440 tothe motor. When the patient needs to urinate, he readily uses theportable remote-control unit to activate the implanted adjustment deviceto temporarily adjust the implanted restriction device 434 to startreleasing the urine passageway to allow him to urinate.

[0167] A pressure sensor 439 is implanted for sensing the pressure onthe restriction device 434. The control unit of the signal receiver 449controls the adjustment device to release the restriction device 434 inresponse to the pressure sensor 439 sensing an abnormal high pressure.

[0168] There are a number of other conceivable alternative embodimentsof the invention that give the same result as the above-describedembodiments. For example, the microprocessor of the external andimplanted, respectively, control unit may be replaced by discretecomponents. The power amplifier of the external control unit may beomitted if the signals generated by the signal generator are strongenough. Therefore the invention is to be accorded the broadestinterpretation of the appended claims to encompass all equivalentstructures and assemblies.

1. An urinary incontinence treatment apparatus for treatment of apatient, who suffers from urinary incontinence, comprising an adjustablerestriction device (2;48;60,62;88;110;122;126,128;130;434) implantablein the patient for contracting a portion of the urethra or urine bladderto form a restricted urine passageway therein, and an operableadjustment device (12;52;66;90,92;104;110) implantable in the patientfor adjusting the restriction device to change the restriction of theurine passageway, the adjustment device, characterised in that therestriction device is non-inflatable, and the adjustment device isinoperable by permanent static magnetic energy and adapted to,mechanically adjust the restriction device to restrict the urinepassageway to prevent urine from passing therethrough and enlarge theurine passageway to allow urine to pass therethrough.
 2. An apparatusaccording to claim 1, wherein the adjustment device(12;52;66;90,92;104;110) is adapted to adjust the restriction device ina non-magnetic or non-thermal manner.
 3. An apparatus according to claimclaim 1 or 2, wherein the adjustment device is powered.
 4. An apparatusaccording to any of claims 1-3, wherein; the restriction device isadapted to control the cross-sectional area of the urine passageway. 5.An apparatus according to claim 4, wherein the restriction device isoperable to open and close the urine passageway.
 6. An apparatusaccording to claim 5, wherein the restriction device is adapted tosteplessly control the cross-sectional area of the urine passageway. 7.An apparatus according to any one of claims 1-6, further comprising apowered operation device for operating the adjustment device.
 8. Anapparatus according to any one of claims 1-7, wherein the restrictiondevice comprises an element to be placed on one side of said portion ofthe urethra or urine bladder, and the adjustment device is adapted tosqueeze said portion of the urethra or urine bladder between the elementand the human bone or tissue to restrict the urine passageway.
 9. Anapparatus according to any one of claims 1-7, wherein the restrictiondevice comprises at least one elongated restriction member(2;48;60,62;88) and forming means (10;94;106;108;118;132) for formingthe restriction member into at least a substantially closed loop aroundsaid portion of the urethra or urine bladder, the loop defining arestriction opening, whereby the adjustment device is adapted to adjustthe restriction member in the loop to change the size of the restrictionopening.
 10. An apparatus according to claim 9, wherein the restrictiondevice comprises several elongated restriction members (2;48;60,62;88)to be formed into at least substantially closed loops around the urethraor urine bladder.
 11. An apparatus according to claim 9 or 10, wherein,the adjustment device (12;52;66;90,92) is adapted to adjust the,longitudinal extension of the elongated restriction member in said loopto change the size of the restriction opening.
 12. An apparatusaccording to, claim 11, wherein the restriction member (2;48) comprisesa main portion and two elongated end portions (4,6), and the adjustmentdevice (12;52;66;90,92) is adapted to establish longitudinal relativedisplacement between the end portions of the restriction member, suchthat the size of the restriction opening (3) is adjusted.
 13. Anapparatus according to claim 12, wherein the adjustment device(12;52;66;90,92) comprises a movement transferring member(14;40;78,90;80,92) in engagement with at least one of the end portions(4,6) of the restriction member and operable to displace said one endportion relative to the other end portion of the restriction member. 14.An apparatus according to claim 13, further comprising a motor (22),which is fixed relative to the main portion of the restriction member(2) and has a rotating drive shaft (32) operatively connected to hemovement transferring member (14).
 15. An apparatus according to claim14, wherein the motor is positioned relative to the elongatedrestriction member such that the drive shaft extends in parallel with achord in said loop of the restriction member.
 16. An apparatus accordingto claim 11, wherein the elongated restriction member (48,50) islongitudinally resilient and the adjustment device comprises acontraction means (52) adapted to longitudinally contract the resilientrestriction member.
 17. An apparatus according to claim 16, wherein theelongated restriction member comprises a substantially nonresilient mainportion (48) and an end portion forming an elongated helical spring(50), which is contractible by the contraction means (52).
 18. Anapparatus according to claim 17, wherein the contraction means comprisesan elongated flexible pulling member (52) connected to the main portion(48) of the restriction member and extending through the helical spring(50) to contract the helical spring against an arresting member (56),which is fixed relative to the main portion of the restriction member.19. An apparatus according to claim 9, wherein the restriction membercomprises an elongated helical spring (60) having a free end, and a body(64) to which said spring is nonrotatably secured at its opposite end,the adjustment device (66) being adapted to rotate the helical spring inone direction to enlarge the coils of the helical spring tolongitudinally contract the elongated helical spring and to rotate thehelical spring in the opposite direction to reduce the size of the coilsof the helical spring to longitudinally extend the helical spring. 20.An apparatus according to claim 19, wherein the restriction membercomprises a further elongated helical spring (62) having a free end andnonrotatably secured to the body (64) at its opposite end, and theadjustment device comprises a drive shaft (66) having two opposite endportions connected to the helical springs, respectively, at their freeends, the helical coils forming left and right hand helices,respectively.
 21. An apparatus according to claim 20, wherein therestriction member comprises a further elongated helical spring (62)having a free end and nonrotatably secured to the body (64) at itsopposite end, and the adjustment device comprises a gearing (70) havingan input shaft (78) and two opposite aligned output shafts (74,76)connected to the helical springs (60,62), respectively, at their freeends, the input shaft being connected to the output shafts such that theoutput shafts rotate in the opposite directions upon rotation of theinput shaft, the helical coils forming the same helices.
 22. Anapparatus according to claim 9, wherein the restriction member(88;110;122) forms a radially innermost circumferential confinementsurface in said loop of the restriction member, and the adjustmentdevice (104;112) is adapted to mechanically adjust the restrictionmember such that at least a portion of thy confinement surface issubstantially radially displaced in said loop.
 23. An apparatusaccording to claim 22, wherein the adjustment device comprises anelongated voltage responsive element (104) forming part of theconfinement surface and capable of bending into a bow in response to avoltage applied across the element, the radius of curvature of said bowbeing adjustable by changing the level of the voltage.
 24. An apparatusaccording to claim 22, wherein the restriction member comprises anelastic annular element (110) forming the confinement surface, and theadjustment device (112) is adapted to change the diameter of the elasticannular element.
 25. An apparatus according to claim 22, wherein theforming means comprises a substantially rigid outer annular element(118), and the restriction member comprises an elongated helical spring(60) extending internally along the outer annular element and contactingthe latter, the helical spring forming part of the circumferentialconfinement surface and having a free end, and a body to which thehelical spring is nonrotatably secured at its opposite end, theadjustment device being adapted to rotate the helical spring in onedirection to enlarge the coils of the helical spring to contract thecircumferential confinement surface and to rotate the helical spring inthe opposite direction to reduce the size of the coils of the helicalspring to expand the circumferential confinement surface.
 26. Anapparatus according to claim 22, wherein the forming means comprises asubstantially rigid outer annular element (118), and the restrictionmember comprises a first (60) and a second (62) elongated helical springextending internally along the outer annular element and contacting thelatter, the helical springs forming part of the circumferentialconfinement surface, the first and the second spring, respectively,having a free end, and a body to which the first and the second spring,respectively, is nonrotatably secured at its opposite end, theadjustment device being adapted to rotate the first and the secondspring, respectively, in one direction to enlarge the coils of thespring to contract the circumferential confinement surface and to rotatethe first and the second spring, respectively, in the opposite directionto reduce the size of the coils of the spring to expand thecircumferential confinement surface.
 27. An apparatus according to claim9, wherein the restriction member comprises at least two separateelements, at least one of which is pivoted such that it is pivoted in aplane in which said loop of the restriction member extends, and theadjustment device is adapted to turn said pivoted element to change thesize of said restriction opening.
 28. An apparatus according to any oneof claims 1-7, wherein the restriction device comprises at least twoframe elements (126 and 128), which are foldable towards each other bythe adjustment device.
 29. An apparatus according to claim 28, whereinthe foldable frame elements comprise two substantially semi-circularframe elements (126 and 128), which are hinged together such that thesemicircular elements are swingable relative to each other from a fullyopen state in which they substantially form a circle to a fully foldedstate in which they form a semicircle.
 30. An apparatus according toclaim 9, wherein the elongated restriction member (130) is elastic andvaries in thickness as seen in a cross-section therethrough, and theadjustment device is adapted to turn the restriction member around thelongitudinal extension thereof.
 31. An apparatus according to claim 9,wherein the forming means comprises a spring material forming theelongated restriction member into the loop, such that the restrictionopening has a predetermined size, and the adjustment device is adaptedto adjust the restriction member against the spring action of the springmaterial.
 32. An apparatus according to claim 31, wherein the springmaterial is integrated in the restriction member.
 33. An apparatusaccording to claim 9, wherein the forming means (10;94;106;108;118;132)is adapted to form the restriction member(2;48;60,62;88;110;122;126,128;130) into a loop having a predeterminedsize or a size selected from several predetermined sizes.
 34. Anapparatus according to claim 9, wherein the adjustment device(12;52;66;90;104;110) is adapted to change the size of the restrictionopening (3) such that the outer circumferential confinement surface ofthe restriction member (2;48;60,62;88;110;122;126,128;130) is changed.35. An apparatus according to claim 9, wherein the adjustment device(12;52;66,90;104;110;434) is adapted to change the size of therestriction opening (3) such that the outer circumferential confinementsurface of the restriction member(2;48;60,62;88;110;122;126,128;130:436) is unchanged.
 36. An apparatusaccording to claim 9, wherein the elongated restriction member (404) isflexible, and the adjustment device (410) is adapted to pull a firstportion (404A) of the flexible restrictions member from a second portion(404B) of the flexible restriction member opposite the first portion inthe loop to squeeze said portion of the urethra or urine bladder (406)between two opposite lengths of the elongated flexible restrictionmember to restrict the urine passageway in said portion of the urethraor urine bladder (406), and to release said portion of the urethra orurine bladder (406) from the flexible restriction member to enlarge theurine passageway (FIGS. 36A,36B).
 37. An apparatus according to any oneof claims 1-7, wherein the restriction device (412) comprises at leasttwo elements (414) to be placed on different sides of said portion ofthe urethra or urine bladder (406), and the adjustment device is adaptedto squeeze said portion of the urethra or urine bladder (406) betweenthe elements to restrict the urine passageway in said portion of theurethra or urine bladder (406), and to release said portion of theurethra or urine bladder (406) from the elements to enlarge the urinepassageway (FIGS. 37A,37B).
 38. An apparatus according to any one ofclaims 1-7 wherein the restriction device (418) comprises at least twoarticulated clamping elements (420) to be positioned on opposite ordifferent sides of said portion of the urethra or urine bladder (406),and the adjustment device (422) is adapted to turn the clamping elementstoward each other to clamp said portion of the urethra or urine bladder(406) between the clamping elements to restrict the urine passageway insaid portion of the urethra or urine bladder (406), and to turn theclamping elements away from each other to release said portion of theurethra or urine bladder (406) from the clamping elements to enlarge theurine passageway (FIG. 38).
 39. An apparatus according to any one ofclaims 1-7, wherein the restriction device is adapted to bend a portionof said portion of the urethra or urine bladder (406) (FIGS. 39A-44B).40. An apparatus according to claim 39, wherein the restriction device(424) comprises at least two bending members (426-430) to be positionedon opposite or different sides of said portion of the urethra or urinebladder (406) and to be displaced relative to each other along the urinepassageway in said portion of the urethra or urine bladder (406), andthe adjustment device (432) is adapted to move the bending membersagainst said portion of the urethra or urine bladder (406) to bend it torestrict the urine passageway, and to move the bending members away fromsaid portion of the urethra or urine bladder (406) to release it fromthe bending members to enlarge the urine passageway (FIGS. 39A-39C). 41.An apparatus according to claim 40, wherein the bending members compriserollers.
 42. An apparatus according to any one of claims 1-7, whereinthe restriction device is adapted to rotate a portion of the urethra orurine bladder.
 43. An apparatus according to claim 7, wherein theoperation device comprises a motor (22;68;124;130;136) operativelyconnected to the adjustment device (12;52;66;90,92;104;110).
 44. Anapparatus according to claim 43, wherein the operation device comprisesa reverie servo connected between the motor and the adjustment device.45. An apparatus according to claim 43 or 44, comprising, an implantablereversing device for reversing the motor.
 46. An apparatus according toany of claims 43-45, wherein the motor (22;68;124;130;136) is fixed tothe restriction device.
 47. An apparatus according to any of claims3-45, wherein the motor (22) is remote from the restriction member (2)and is connected to the adjustment device (14) by a power transmissionconduit (24).
 48. An apparatus according to claim 7, wherein theoperation device comprises a servo means.
 49. An apparatus according toclaim 48, wherein the servo means comprises a motor, preferably anelectric motor.
 50. An apparatus according to claim 49, wherein themotor is reversible.
 51. An apparatus according to claim 7, wherein theoperation device comprises hydraulic means (54) for operating theadjustment device (52).
 52. An apparatus according to claim 51, furthercomprising a reservoir (204;210;216) containing a predetermined amountof fluid for supplying the hydraulic., means with fluid.
 53. An,apparatus according to claim 52, wherein the reservoir (21) defines achamber fox the predetermined amount of fluid and the hydraulic means(22) is adapted to change the volume of the chamber.
 54. An apparatusaccording to claim 52 or 53, wherein the hydraulic means comprises apump (212) adapted to pump fluid between the reservoir (204) and theadjustment device (202).
 55. An apparatus according to any of claims51-54, wherein the hydraulic means is devoid of any non-return valve.56. An apparatus according to any one of claims 52-55, wherein thehydraulic means comprises a reverse servo (210,214;276-286).
 57. Anapparatus according to claim 56, wherein the reverse servo is manuallyoperated.
 58. An apparatus according to claim 56, wherein the reverseservo is powered.
 59. An apparatus according to any of claims 56-58,wherein the hydraulic means comprises first and second wall portions ofthe reservoir (204), and the reverse servo is adapted to providerelative displacement between the first and second wall portions of thereservoir.
 60. An apparatus according to any one of, the precedingclaims, further comprising a wireless remote control (22,326,332-344)for non-invasively controlling the adjustment device.
 61. An apparatusaccording to claim 60, wherein the remote control (22,326,332-344)comprises a separate signal transmitter and/or receiver (332,336) and animplantable signal receiver and/or transmitter (334,338), fortransmitting and/or receiving a control signal.
 62. An apparatusaccording to claim 61, wherein the signal receiver (334,338) comprises acontrol unit (338) adapted to control the adjustment device(12;52;66;90,92;104;110) in response to the control signal.
 63. Anapparatus according to claim 62, further comprising an implantableenergiser unit (336) for providing energy to energy consuming componentsof the apparatus to be implanted in the patient.
 64. An apparatusaccording to any of claims 60-63, further comprising an implantablemotor (22) for operating the adjustment device (12;52;66;90,92;104;110).65. An apparatus according to claims 63 and 64, wherein the control unit(338) is adapted to control the energiser unit (336) to power the motor(22) with energy in response to the control signal.
 66. An apparatusaccording to claim 64 or 65, wherein the motor (22) is an electricmotor.
 67. An apparatus according to claim 63, wherein the energiserunit (326) is adapted to transform energy from the control signal, as itis transmitted to the signal receiver (334,338), into electric energy.68. An apparatus according to claim 63 or 67, wherein the energiser unit(26) is adapted to transform energy from the control signal into adirect or alternating current.
 69. An apparatus according to claim 67,further comprising an implantable electric motor (22) for operating theadjustment device (12;52;66;90,92;104;110), wherein the energiser unit(326) comprises a rechargeable electric power supply (58) for storingthe electric energy and the control unit (338) is adapted to power theelectric motor (22) with energy from the rechargeable electric powersupply in response to the control signal.
 70. An apparatus according toclaim 63, wherein the energiser unit (326) comprises a battery, anelectrically operable switch adapted to connect the battery to thesignal receiver in (334,338) an “on” mode when the switch is powered andto keep the battery disconnected from the signal receiver in a “standby”mode when the switch is unpowered, and a rechargeable electric powersupply for powering the switch.
 71. An apparatus according to claim 70,wherein the control unit (338) is adapted to power the electric motor(22) with energy from the battery in response to a control signalreceived from the signal transmitter (332,336), when the switch is inits “on” mode.
 72. An apparatus according to claim 63, furthercomprising an external energy transmitter for transmitting wirelessenergy, wherein the energiser unit comprises a battery and a switchoperable by the wireless energy transmitted by the external transmitter,for connecting the battery to the signal receiver in an “on” mode whenthe switch is powered by the wireless energy and to keep the batterydisconnected from the signal receiver in a “standby” mode when theswitch is unpowered.
 73. An apparatus according to claim 1, furthercomprising an implantable energiser unit (336) for providing energy toenergy consuming components of the apparatus to be implanted in thepatient.
 74. An apparatus according to claim 73, further comprising anexternal energy transmitter for transmitting wireless energy, whereinthe energiser unit is adapted to transform the wireless energy intoelectric energy.
 75. An apparatus according to claim 74, furthercomprising an implantable electric motor (22) for operating theadjustment device (12;52;66;90,92;104,110), wherein the energiser unit(326) is adapted to power the electric motor (22) with the electricenergy transformed from the wireless energy.
 76. An apparatus accordingto claim 73, further comprising an external energy transmitter fortransmitting wireless energy, wherein the energiser unit comprises abattery and a switch operable by the wireless energy transmitted by theexternal transmitter, for connecting the battery to the implantableenergy consuming components of the apparatus in an “on” mode when theswitch is powered by the wireless energy and to keep the batterydisconnected from the energy consuming components in a “standby” modewhen the switch is unpowered.
 77. An apparatus according to claim 72 or75, wherein the external energy transmitter is adapted to directly powerthe switch with the wireless energy to switch into the “on”-mode.
 78. Anapparatus according t claim 60, wherein the remote control(22,326,332-344) is capable of obtaining information from implantablecomponents of the apparatus and of commanding the adjustment device(12;52;66;90;104;110) to adjust the restriction device(2;48;60,62;88;110;122;126,128;130;434) in response to obtainedinformation.
 79. An apparatus according to claim 1, further comprisingimplantable electrical components including at least one voltage levelguard.
 80. An apparatus according to claim 1, further comprising,implantable electrical components including a single voltage.
 81. Anapparatus according to claim 79 or 80, wherein the electrical componentsare devoid of any current detector and/or charge level detector.
 82. Anapparatus according to any of claims 79-81, further comprising animplantable capacitor or accumulator, wherein the charge or discharge ofthe capacitor or accumulator is controlled by use of the voltage levelguard.
 83. An apparatus according to claim 1, further comprising anenergy transfer means (22,326,332-344) for wireless transfer of energyfrom outside the patient's body to the adjustment device and/or otherenergy consuming implantable components of the apparatus.
 84. Anapparatus according to claim 83, wherein them energy transfer means isadapted to intermittently transfer, the energy in the form of a train ofenergy pulses for direct use in connection with the energising of theenergy consuming components of the apparatus.
 85. An apparatus accordingto claim 84, wherein the energy transfer means is adapted to transferelectric energy, and further comprising an implantable capacitor forproducing the train of energy pulses.
 86. An apparatus according toclaim 82 or 85, wherein the capacitor has a capacity less than 0,1 μF.87. An apparatus according to claim 83, further comprising animplantable motor (22) or pump for operating the adjustment device(12;52;66;90,92;104;110), wherein the energy transfer means is adaptedto directly power the motor or pump with transferred energy.
 88. Anapparatus according to claim 1, further comprising an implantable motoror pump for operating the adjustment device, and an energy transmissiondevice adapted to transmit wireless energy in the form of an magneticfield or electromagnetic waves for direct power of the motor or pump, asthe wireless energy is being transmitted.
 89. An apparatus according toclaim 88, wherein the pump is not a plunger type of pump.
 90. Anapparatus according to claim 83, wherein the energy transfer means isadapted to transfer wireless energy in the form of electromagnetic wavesexcluding radio waves.
 91. An apparatus according to claims 83 or 84,wherein the energy transferred by the energy transfer means comprises anelectric field or a magnetic fiend.
 92. An apparatus according to claims83 or 84, wherein the energy transferred by the energy transfer meanscomprises a signal.
 93. An apparatus according to claim 61 or 92,wherein the signal comprises digital or analog pulses.
 94. An apparatusaccording to claim 93, wherein the digital or analog pulses comprise amagnetic field or an electric field.
 95. An apparatus according to claim61,91 or 92, wherein the signal comprises a wave signal.
 96. Anapparatus according to claim 95, wherein the wave signal comprises anelectromagnetic wave signal, a sound wave signal or a carrier wavesignal.
 97. An apparatus according to any one of the preceding claims,further comprising a pressure sensor for directly or indirectly sensingthe pressure against the restriction device.
 98. An apparatus accordingto claim 97, wherein the restriction device is controlled in response tosignals from the pressure sensor.
 99. An apparatus according to claim 1,further comprising an implantable energy transforming device fortransforming wireless energy directly or indirectly into energydifferent than the wireless energy for operation of the restrictiondevice.
 100. An apparatus according to claim 99, wherein the energytransforming device transforms the wireless energy into kinetic energyfor operation of the restriction device.
 101. An apparatus according toclaim 99, wherein the energy transforming device transforms the wirelessenergy in the form of sound waves into electric energy for operation ofthe restriction device.
 102. An apparatus according to any one of thepreceding claims, further comprising an implantable reversing device,wherein the restriction device is capable of performing a reversiblefunction and the reversing device reverses the reversible function. 103.An apparatus according to any one of the preceding claims, furthercomprising an implantable accumulator or battery and means forcontrolling the accumulator or battery from outside the patient's bodyto supply energy to the adjustment device and/or other implantableenergy consuming components of the apparatus.
 104. An apparatusaccording to claim 1, wherein the adjustment device is adapted to adjustthe restriction device in a non-invasive or non-manual manner.
 105. Anapparatus according to claims 7,43-59, further comprising an implantablegear transmission (42) operatively connecting the operation device andadjustment device.
 106. An apparatus according to claim 101, wherein theenergy transforming device transforms the wireless energy in the form ofsound waves directly into electric energy.
 107. An apparatus accordingto claim 101,106 or 83, wherein the energy transforming device comprisesa capacitor.
 108. An apparatus according to claim 107, wherein thecapacitor is adapted to produce electric pulses from the transformedelectric energy.
 109. An apparatus according to claim 58, where n thereverse servo comprises a motor, preferably an electric motor.
 110. Anapparatus according to claim 109, wherein the motor is reversible. 111.An apparatus according to claim 96, wherein the carrier signal isfrequency, amplitude or frequency and amplitude modulated.
 112. Anapparatus according to claim 96, wherein the control signal comprises awave signal comprising one of a sound wave signal including anultrasound wave signal, an electromagnetic wave signal including aninfrared light signal, a visible light signal, an ultra violet lightsignal and a laser light signal, a micro wave signal, a radio wavesignal, an x-ray radiation signal, and a gamma radiation signal.
 113. Anapparatus according to claim 52, wherein the hydraulic, means of theoperation device comprises a fluid conduit, the reservoir forming partof the conduit.
 114. An apparatus according to claim 113, wherein thehydraulic means including the conduit are devoid of any non-returnvalve.
 115. An apparatus according to claim 83, wherein the energytransfer means, is adapted to transfer magnetic energy, non-magneticenergy, electromagnetic energy, non-electromagnetic energy, kineticenergy, non-kinetic energy, sonic energy, non-sonic energy, thermalenergy or non-thermal energy.